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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. PROGRASP FORCEPS ENDOSCOPIC INSTRUMENT

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INTUITIVE SURGICAL,INC. PROGRASP FORCEPS ENDOSCOPIC INSTRUMENT Back to Search Results
Model Number 420093-12
Device Problem Device Issue (2379)
Patient Problem Tissue Damage (2104)
Event Date 01/16/2018
Event Type  Injury  
Manufacturer Narrative
The prograsp forceps instrument was returned to intuitive surgical, inc. (isi) and evaluated. Upon visual and microscopic inspection, no damage was found to the instrument's wrist assembly. No sharp edges/ burrs were found. No broken or frayed cable was found at the instrument's wrist. Manual input the disk knob exhibited intuitive motion. The instrument was placed and driven on a da vinci in-house system. The instrument passed recognition and engagement tests. The instrument moved intuitively with full range of motion in all directions. The grips opened and closed properly and performed grip function without any issues. No interference/issues occurred with the objects and the distal pulley system. No difficulty was observed while removing and installing the instrument on a system arm. Levers were still present on the instrument and were easily depressed to remove the instrument during disengagement of the instrument with various cannulas. Isi has reviewed the site's system logs with a procedure date of (b)(6) 2018. No related system errors were found to have occurred during the surgical procedure based on the available system logs. This complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, bowel tissue allegedly got stuck around the distal pulley system of the prograsp forceps instrument. The patient reportedly sustained a small bowel tear during attempts to remove the stuck tissue. As a result, the bowel tear was repaired with one suture. However, the root cause of the operative complication is unknown. The prograsp forceps instrument was returned to isi and no issues were found with an evaluation of the instrument.
 
Event Description
It was reported that during a da vinci-assisted prostatectomy procedure, bowel serosa allegedly got stuck in the distal pulley system of the prograsp forceps instrument. The event occurred after the surgeon had reportedly used the instrument to retract bowel out of the pelvis. In order to retrieve the prograsp forceps instrument, the surgeon had to tease out the stuck tissue from the instrument's pulley system using a monopolar curved scissors (mcs) instrument. During this process, a small tear was identified on the bowel serosa. The surgeon repaired the bowel defect with a single suture. The prograsp forceps instrument was replaced with another instrument and the surgical procedure was completed. No post-operative complications were reported.
 
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Brand NamePROGRASP FORCEPS
Type of DeviceENDOSCOPIC INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.,
950 kifer rd
sunnyvale CA
Manufacturer Contact
tabitha reed
950 kifer rd
sunnyvale, CA 
4085232420
MDR Report Key7251674
MDR Text Key99351341
Report Number2955842-2018-00084
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number420093-12
Device Lot NumberN10170424 095
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/08/2018 Patient Sequence Number: 1
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